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Regulatory Affairs and Compliance

Overview

Pharmaceutical (drug and biologic) and medical device companies today are challenged with a stringent and continually evolving regulatory environment, together with changing technologies and global economic considerations.

This program is designed to help meet the expanding need for regulatory affairs professionals who are able to understand and interpret regulations across the full spectrum of the product lifecycle and who can demonstrate both operational and strategic effectiveness. It covers a variety of key topics including regulatory requirements, submissions, strategy, compliance during pre-market and post-market phases, and also addresses requirements in the major international markets.

Participants will learn the fundamentals of regulatory affairs, gain exposure to industry practices, and discover practical applications to develop the interpretive and analytical skills required of a regulatory affairs professional.

This program offers two-tracks: pharmaceuticals (drugs and biologics) or medical devices. With unique products, organizations, regulations, and industry standards, pharmaceuticals and medical devices are often treated as distinct industries. The specialized coursework provides the focused training needed to understand regulatory expectations and to apply this regulatory knowledge in pharmaceutical and medical device organizations.


Members save 10% on one
UCI DCE course per quarter.

Who Should Enroll

This program offers a path for students new to the pharmaceutical and/or medical device industries and to individuals currently employed within these industries who are new to the field of pharmaceutical or medical device regulatory affairs. Additionally, this program benefits current industry professionals with focused regulatory or compliance experience who are seeking a change in practice setting or job function.

Career Insight

Occupational summary for managers in the US. Source: Economic Modeling Specialists Intl.

479,965
Annual Job Openings
(2019)
9.8%
Projected Growth
(2019-2029)
$107k
Median Salary
(Highly experienced workers can earn up to $183k)
Life Science Industry in Orange County

Program Benefits

  • Gain knowledge on the product development process and the product lifecycle for pharmaceuticals and medical devices
  • Learn how to maintain regulatory compliance across the product lifecycle
  • Further your career with a studies approach in regulatory intelligence by effectively utilizing key databases and resources to gather critical information relevant to the practice of regulatory affairs
  • Understand FDA and regulatory agencies in other major international markets in terms of structure, regulations, and enforcement
  • Learn requirements and approaches to create and maintain compliance with quality systems, including strategies for minimizing and handling potential crises
  • Earn professional development credits to maintain your RAC credential with RAPS – Regulatory Affairs Professional Society
  • Establish an educational pathway for advanced education in FDA regulations, compliance, and policy

Course Schedule

Candidates choose either the Pharma or Device Track for their required courses.

Elective Courses

TitleWinterSpringSummerFall
Required Courses - Pharma Track
PHRMSCI X480
Intro to Reg Affairs and Compliance for Drugs, Biologics, and Medical Devices (2.00 Units)
PHRMSCI X480
  to be scheduled   Online
EECS X445.26
Regulatory Requirements for Pharmaceutical Products (3.00 Units)
EECS X445.26
  to be scheduled Online Online
BIO SCI X450
Fundamentals of Clinical Trials (3.00 Units)
BIO SCI X450
to be scheduled   Online  
PHRMSCI X481
Post-Approval Compliance Requirements for Pharmaceutical Products (2.00 Units)
PHRMSCI X481
to be scheduled   Online  
Required Courses - Device Track
PHRMSCI X480
Intro to Reg Affairs and Compliance for Drugs, Biologics, and Medical Devices (2.00 Units)
PHRMSCI X480
  to be scheduled   Online
EECS X445.2
Regulatory Requirements for Medical Devices (3.00 Units)
EECS X445.2
to be scheduled to be scheduled   Online
BME X413.2
Regulatory Affairs for Post-Market Approval (2.00 Units)
BME X413.2
  to be scheduled    
BME X412
Regulatory Affairs Planning and Management: Concept Review and Evaluation (3.00 Units)
BME X412
to be scheduled      
Elective Courses (5 units)
PHRMSCI X493
Drug Safety and Pharmacovigilance (2.00 Units)
PHRMSCI X493
to be scheduled      
MGMT X442.6
Medical Device Quality Systems (3.00 Units)
MGMT X442.6
to be scheduled   Online  
MGMT X445
Medical Device Marketing (3.00 Units)
MGMT X445
  to be scheduled   Online
PHRMSCI X490
Overview of Global Regulatory Affairs (3.00 Units)
PHRMSCI X490
      Online
BME X408
Medical Device Life-Cycle Management (3.00 Units)
BME X408
  to be scheduled   Online
PHRMSCI X495
Application of ICH Guidelines - Regulatory Strategy Development and Dossier Preparation (2.00 Units)
PHRMSCI X495
    Online  

Course schedules are subject to change. Individual courses may be taken without enrolling in the full program.

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Academic Calendar

Event Summer 2020 Fall 2020 Winter 2021 Spring 2021
Registration Begins (after 2pm) Apr 24 Jul 16 Oct 22 Jan 21
Courses Begin* (week of) Jun 22 Sep 21 Jan 4 Mar 29
Courses End* (week of) Sep 7 Dec 14 Mar 15 Jun 7
Parking Permits Expire Sep 30 Dec 31 Mar 31 Jun 30
Administrative Holidays Jul 3, Sep 7 Nov 11, Nov 26-27, Dec 24-25, Dec 31 Jan 1, Jan 18, Feb 15 Mar 26, May 31

*Actual dates may vary by program.

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Learn How To Earn Your CertificateCertificate Eligibility and Requirements

A certificate is awarded upon completion of 15 credit units (10 required from chosen track [pharma or device] and 5 elective credit units), with a grade of “C” or better in each course. NOTE: Six credit units may be counted towards the Clinical Trials: Medical Device and Drug Development or Medical Device Development Certificate Program when courses are shared.

To become an official candidate in the program, students pursuing the certificate must submit a Declaration of Candidacy with a non-refundable $125 application fee. Students are encouraged to declare candidacy as soon as possible, but no later than after the third course in the program. To receive the digital certificate after completing all program requirements, students must submit a Request for Certificate. All requirements must be completed within five (5) years after the student enrolls in his/her first course. Students not pursuing the certificate are welcome to take as many individual courses as they wish.

Transfer Credits

Graduates from UCI Division of Continuing Education's Regulatory Affairs & Compliance program are eligible to transfer credits to:

Note: Any student wishing to transfer credits must obtain a “B” or better in each course.

Frequently Asked Questions

  • How much does the program cost?
  • Fees for each course vary from $450 - $745 based on unit value. There is also a one-time candidacy declaration fee of $125, to be paid after your second class. Therefore, the entire program costs $5,050. Note that you pay for each class as you enroll, as opposed to the entire tuition sum at once. Please keep in mind that this cost does not include textbooks, which some of our instructors do require. Textbook information for specific courses can be found on our website on the enrollment page. Students may purchase textbooks from the vendor of their choice. Prices are subject to change without notice.
  • How long will it take me to complete the entire program?
  • It depends on how many course you can take each quarter. A certificate is awarded upon completion of 15 total units, the 10 required courses (from the chosen track, pharma or device) and a minimum of 5 elective credit units, each with a letter grade of “C” or better. On average you can complete the program in 12-18 months. Most students who work full time take one or two classes per quarter, depending on their work schedules and other obligations. You can take as many courses as you wish simultaneously, but we strongly recommend starting with one or two to ensure you have the necessary time to devote to the course(s).
  • If I want to take both the Pharma and the Device track, will I receive two Certificates?
  • Yes, you will receive two separate Certificates, one indicating a Certificate in Regulatory Affairs & Compliance for Pharmaceuticals and a separate one indicating a Certificate in Regulatory Affairs & Compliance for Medical Devices. You must take all the required courses between both tracks, except for the Intro course (PHRMSCI X480), which will be applied to both tracks; you only need to take it once. You can share up to six units or two electives courses between both tracks. Please note that you will also need to apply for candidacy into both Certificate Programs to earn both Certificates.
  • Do I need to do the Intro course (PHRMSCI X480) again or if I have taken it once, it'll be applied to both tracks?
  • Yes, the Intro course (PHRMSCI X480) will be applied to both tracks; you only need to take it once.
  • If I am interested in taking courses from other Life Sciences Certificate Programs can these programs share electives?
  • Yes, you can share up to six units or two Electives courses between the Clinical Trials: Medical Device and Drug Development Certificate Program and the Medical Device Development Certificate Program.
  • Do I have to apply and be accepted before I start?
  • No. This is an open-enrollment program, and you will not have to provide transcripts or prove prerequisites before you begin.
  • Where can I find the course schedule? Do I have to take the classes in order?
  • The course schedule can be found here. You may take the classes in any order that you like. However, we strongly recommend that you start with PHRMSCI X480, Introduction to Regulatory Affairs and Compliance for Drugs, Biologics, and Medical Devices, which is offered in fall and spring quarter terms.
  • Can I complete the entire program online?
  • Yes, this is a fully online program.
  • I've never taken an online class. How does it work? Is it self-paced?
  • No, the classes are not self-paced. Our online classes take place in an asynchronous online environment, meaning there will not be a day of the week or time of day that you will need to be online. You can log in when you have time to do so. However, the courses are structured week-to-week, from Monday to Sunday, and you are expected to log in multiple times during the week to keep up with class discussions and assignments. Some instructors may hold optional synchronous sessions which happen in real time. These sessions will be recorded and posted in the course for all students to access.
  • I am an international student / I am located overseas – am I able to enroll?
  • Yes. As an open-enrollment program, international students are welcome in the program. Please note that if English is not your native language, enrollment in this program assumes that you have a working proficiency in English to allow you to engage in high-level academic discourse without any additional language coaching. If you are interested in taking the program fully online, you may enroll in courses via the Continuing Education website at your convenience and on a quarter by quarter basis. You are not required to have a student visa while taking online courses from your home county.

    If you wish to apply for an F-1 student visa to study in person at UC Irvine Division of Continuing Education (DCE), you must formally apply to UC Irvine DCE's International Programs and request an I-20. Please keep in mind that not all evening certificate programs are available to F-1 student visa holders based on the availability of classes that meet on campus. We cannot issue an I-20 for fully online programs. Please visit International Programs or email uciesl@uci.edu for more information.
  • Do you offer job placement at the end of the program?
  • No. While UCI DCE does not offer placement services, our certificate certainly puts you in a good position to find employment. Additionally, the networking to be done in the class can also be invaluable. Our advisors, instructors, and a good number of our students, are current professionals in the industry, and are an excellent resource for hiring trends and opportunities.
  • Is UC Irvine Division of Continuing Education an accredited institution?
  • Yes. We are affiliated with the University of California system of schools, and are accredited through WASC. DCE programs are all approved by the respective school within UCI. For more information, please visit UCI Accreditation.
  • What is the “declaration of candidacy”? When do I have to complete it?
  • The declaration of candidacy can be thought of as declaring your major for the certificate program. This lets our student services know that you intend to complete the entire program, and puts you on track for the certificate when you have completed all requirements. We strongly recommend that you complete the declaration of candidacy and pay the applicable fee before enrolling into your third class.
  • Are there scholarships or financial aid available for this program?
  • Since UCI DCE is the continuing education unit of the university, we do not offer/accept any federal financial aid or scholarships. If you take courses through us, you may apply directly to private lenders like Wells Fargo for funding. It is recommended that you begin the loan application process early as UCI DCE does not enroll students in courses until payment is received, and applying for a loan does not reserve a space in the course. For more information, please visit Student Loan Programs. If you have any questions regarding student loans, please contact Student Services at 949-824-5414. For more financial information, please go to Financial Information.
  • I can't find the answer to my question.
  • If you have any additional questions, please feel free to contact Kadie Heck at kheck1@uci.edu or (949) 824-7648.

Advisory Committee

  • Richard Chamberlin, Ph.D., Professor and Chair, Pharmaceutical Sciences, University of California, Irvine
  • Michele Dishon, Pharm.D., Director, Drug Safety Operations, Spectrum Pharmaceuticals
  • Sumit Sen, Ph.D., Chemist (Technology-Based Expert), U.S. Food and Drug Administration
  • Del Stagg, Ph.D., Regulatory Consultant, Founder of the Orange County Regulatory Affairs Society (OCRA)
  • Cristiana Zaharia, Ph.D., Manager, Drug Substance Regulatory Strategy, Gilead Sciences, Inc.

On-site Training Available

Our Corporate Training specialists can deliver this program or customize one that fits your organization’s specific needs. Visit Corporate Training or call (949) 824-1847 for information.

English Proficiency Requirement
All certificate programs at UCI Division of Continuing Education (classroom and online formats) require professional-level English language proficiency in listening and note-taking, reading comprehension and vocabulary, written expression, and oral presentation.

Regulatory Affairs and Compliance Education Planning Session
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